EP2633838B1 - Dispositif de maintien pour une membrane pour une application médicale sur l''il et dispositif de tension correspondant - Google Patents

Dispositif de maintien pour une membrane pour une application médicale sur l''il et dispositif de tension correspondant Download PDF

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Publication number
EP2633838B1
EP2633838B1 EP13157162.2A EP13157162A EP2633838B1 EP 2633838 B1 EP2633838 B1 EP 2633838B1 EP 13157162 A EP13157162 A EP 13157162A EP 2633838 B1 EP2633838 B1 EP 2633838B1
Authority
EP
European Patent Office
Prior art keywords
inner ring
outer ring
ring
plunger
eye
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Not-in-force
Application number
EP13157162.2A
Other languages
German (de)
English (en)
Other versions
EP2633838A1 (fr
Inventor
Heinz Körber
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Deutsche Gesellschaft Fuer Gewebetransplantation
Original Assignee
Deutsche Gesellschaft fur Gewebetransplantation - Gemeinnuetzige GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Deutsche Gesellschaft fur Gewebetransplantation - Gemeinnuetzige GmbH filed Critical Deutsche Gesellschaft fur Gewebetransplantation - Gemeinnuetzige GmbH
Publication of EP2633838A1 publication Critical patent/EP2633838A1/fr
Application granted granted Critical
Publication of EP2633838B1 publication Critical patent/EP2633838B1/fr
Not-in-force legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/04Eye-masks ; Devices to be worn on the face, not intended for looking through; Eye-pads for sunbathing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/0008Introducing ophthalmic products into the ocular cavity or retaining products therein
    • A61F9/0017Introducing ophthalmic products into the ocular cavity or retaining products therein implantable in, or in contact with, the eye, e.g. ocular inserts

Definitions

  • the invention relates to a holding device for a membrane for medical use on the eye and a clamping device for positioning the membrane in the holding device.
  • membranes are applied to eye surface treatments and fixed to or on the eye.
  • amnion membrane holders for example from US Pat WO 03/077 794 A2 , known.
  • the amniotic membrane is positioned using variously designed holding devices and prepared for use on the eye.
  • it is proposed to clamp the membrane between an inner and an outer ring, the outer ring being clamped in an inward groove of the inner ring.
  • Alternative attachments of the membrane to the membrane holder are realized by fixing the membrane by means of clamping in a ring with a gap or by sewing the ring to the membrane.
  • a holding device for a membrane and a carrier for the holding device consisting of two concentrically arranged rings, an inner ring being received in an outer ring and the two rings having a common frustoconical inner surface which rests on the eye.
  • WO 2006/058443 A1 discloses a device for protecting the eye during laser treatment.
  • the radiation device is positioned against the eye lens, a membrane protecting the lens from damage and a suction ring locking the arrangement.
  • a holding device for a membrane for medical use on the eye which has an inner ring made of a rigid material and an outer ring made of an elastic material, between which the membrane is held.
  • the inner ring is fully received under tension by an outer ring in an annular groove-like inner ring receptacle.
  • the inner ring receptacle extends from the inside to the outside into the outer ring and the outer ring surrounds the inner ring in a form-fitting manner in a contact area, so that the membrane is arranged and fixed in the contact area between the inner ring and the outer ring.
  • the outer ring is particularly preferably made of silicone and the inner ring is made of steel wire.
  • the inner ring is received by the inner ring receptacle in such a way that the inner ring has no contact with the eye and only the outer ring is in contact with the eye.
  • the inner ring is particularly advantageously formed from a stainless steel wire with the material designation WS1.4310, the ends of which are welded to one another and particularly preferably laser-welded.
  • the outer ring is wedge-shaped in cross-section tapering outwards.
  • the inner flank lies on the eye and the eyelid runs onto the outer flank when you blink your eye.
  • the wedge-shaped design of the outer ring and thus the wedge-shaped run-out increases the wearing comfort of the device, because the eyelid can slide better over the wedge-shaped outer ring.
  • the annular groove-like inner ring receptacle extends radially and horizontally from the inner boundary of the outer ring to the outside and forms a fillet at the outer boundary, the dimensions or diameter of which correspond to the diameter of the inner ring.
  • a clamping device for a membrane is proposed according to the invention, with the aid of which the positioning of the membrane in the holding device can be carried out rationally manually or automatically.
  • the clamping device essentially consists of two parts, an upper part for temporarily holding the inner ring and a lower part for temporarily holding the outer ring of the holding device.
  • the upper part and lower part are movable relative to each other and are placed on top of each other to clamp the membrane.
  • the membrane can be positioned between the upper part and the lower part and means are further provided which guide the inner ring while the membrane is being clamped, taking the membrane with it, into the corresponding inner ring receptacle of the outer ring.
  • the membrane between the inner ring and outer ring is clamped and fixed in the contact area between the inner ring and the outer ring.
  • the upper part of the clamping device has an upper punch for receiving the inner ring and has a positioning cone that is axially movable relative to the upper punch.
  • the positioning cone is designed to strip the inner ring from the upper punch and to push and guide the inner ring into the inner ring receptacle of the outer ring placed opposite on the lower part of the clamping device.
  • the positioning cone can preferably be actuated via a pressure ring and is axially displaceable relative to the upper part.
  • the clamping device advantageously has a pressure stamp which actuates the upper stamp and, like the upper stamp, is designed to be axially displaceable relative to the upper part.
  • the lower stamp of the The lower part is also designed to be axially movable, so that when the pressure stamp is actuated and the upper stamp and the lower stamp adjacent to it move, the outer ring, which is mounted on the lower stamp, is pressed against a stripping cone and rotates around the inner ring while clamping the membrane is stripped between the outer ring and the inner ring.
  • the lower stamp is simulated convexly in the shape of the eyeball and the upper stamp is concave in a corresponding manner.
  • the upper part and the lower part are pivotally connected to one another, the upper and lower punches, the positioning cone and the stripping cone lying in one axis in an open position and in the mounting position for easier fitting of the clamping device with individual parts of the holding device and for Removal of the assembled holding device, the upper part is designed to pivot away from the lower part.
  • the advantages of the invention consist in particular in that the inner ring is completely received by the outer ring in such a way that it does not come into contact with the eye.
  • the outer ring made of flexible and medically well tolerated material completely encloses the inner ring in shape and dimension on the outside as well as above and below and the inside of the inner ring is recessed so far in the inner ring receptacle that the inner ring has no contact with the eye.
  • the membrane is held in a contact area within the annular groove-like inner ring receptacle.
  • the components of the holding device can be produced inexpensively and the clamping device for mounting the inner ring and outer ring with the membrane is easy to operate.
  • a jig 1 is shown in a half-open position.
  • the clamping device 1 essentially consists of an upper part 3 and a lower part 4, which are connected to one another by means of a joint.
  • the upper part 3 can be pivoted onto the lower part 4 by means of a swivel joint.
  • the upper punch 7 is axially displaceable via a pressure stamp 11.
  • the actuation of the pressure stamp 11 leads to an axial displacement of the upper stamp 7 relative to the frame-like upper part 3.
  • a positioning cone 9 is also axially slidably provided on the upper part 3, which is designed to be actuable via an axially movable pressure ring 10.
  • the lower part 4 of the clamping device 1 essentially has a lower punch 8, which is also designed to be axially movable, and also has a scraper cone 15, which is not designed to be movable relative to the lower part 4.
  • the clamping device 1 is handled by first pulling the inner ring 5 made of stainless steel wire onto the upper punch 7 of the upper part 3 in the opened state.
  • the upper punch 7 is cylindrical or slightly conical or chamfered, so that the inner ring 5 is pressed onto the punch 7 by hand without additional aids can be raised or postponed.
  • a small wire spring is provided in a longitudinal groove of the upper punch 7, which holds the pushed-on inner ring 5 with slight tension in the radial direction on the upper punch 7.
  • the outer ring 6 made of silicone is placed with the conical narrow side down on the lower punch 8 and the lip protruding outwards of the outer ring 6, which is wedge-shaped in cross section, is turned inside out.
  • the groove-like inner ring receptacle 13 is oriented vertically and points with the open side upwards and is ready for the insertion of the inner ring 5 into the inner ring receptacle 13 from above.
  • the membrane is placed on the lower punch 8 with the outside that does not come into contact with the eye, the membrane overlapping the punch 8 and the inner ring receptacle 13 in the radial direction.
  • the membrane is now positioned between the upper punch 7 and the lower punch 8. Subsequently, the pressure ring 10 is moved down, whereby the positioning cone 9 moves relative to the upper punch 7 and thereby grips the inner ring 5 and leads into the underlying groove of the inner ring receptacle 13 of the outer ring 6, the intermediate membrane being carried along and between which in the Inner ring receptacle 13 received inner ring 5 and the outer ring 6 is clamped.
  • the pressure stamp 11 is actuated, as a result of which the upper stamp 7 together with the lower stamp 8 are moved axially downward and the outer ring 6 resting on the lower stamp 8 is pressed against the stripping cone 15, which leads to the fact that the Outer ring 6 upwards folds back with its wedge-shaped end and thereby fixes the inner ring 5 with the membrane firmly in the inner ring receptacle 13 of the outer ring 6 under tension.
  • the wedge-shaped lip of the outer ring 6 snaps back up as described and the membrane is fully clamped. Thereafter, the upper part 3 is pivoted away from the lower part 4 and the prepared holding device, consisting of inner ring 5, outer ring 6 and the membrane, is released for removal from the clamping device 1.
  • the membrane 12 spans the entire diameter of the inner ring 5, is held between the inner ring 5 and the outer ring 6 and, as far as protruding, lies against the outer ring 6 on the inner flank and is thus between the eye and the outer ring 6, which is included appropriate protrusion of the membrane has no contact with the eye. This is particularly advantageous in order to avoid material-related irritation of the surface of the eye.
  • a holding device 2 is shown in a three-dimensional view, which shows the clamped membrane 12 and the outer ring 6.
  • the inner ring 5 is almost completely covered by the outer ring 6 and can only be seen in the upper part of the figure.
  • the outer and inner contours of the outer ring 6 are conical, which results in the wedge-shaped cross section of the outer ring 6.
  • the upper limit of the outer ring 6 is rounded in order to achieve the greatest possible comfort of the holding device 2 on the eye.
  • FIG 3 the cross section of the outer ring 6 of the holding device 2 is shown enlarged.
  • the wedge-shaped tapering of the legs in the lower area serves to increase the wearing comfort of the holding device 2 for medical use on the eye.
  • the cross section of the outer ring 6 has an annular groove-like inner ring receptacle 13 which extends radially outwards and which follows is limited on the outside by the contact area 14.
  • the lower flank of the wedge and inner surface of the outer ring 6 rests on the eye and adapts to the respective contour of the eyeball through the highly flexible silicone material, the membrane 12 being arranged between the outer ring 6 and the eye with appropriate dimensions.
  • neither the inner ring 5 nor the outer ring 6 has direct contact with the surface of the eye.
  • the upper flank of the wedge and the outer surface of the outer ring 6, however, is swept by the eyelid when the eyelid moves and is designed to be compatible with it.
  • FIG. 4 the holding device 2 with the outer ring 6 and the inner ring 5 and the membrane 12 is shown in assembled form in a side view in cross section.
  • the membrane 12 follows the rounding of the eye in the area of the cornea and is enlarged between the inner ring 5 and the outer ring 6 in FIG Figure 3 shown contact area 14 clamped.
  • Figure 5 shows one the Figure 4 Additional top view of the outer ring 6 with the inner ring receptacle 13 and the membrane 12 shown with hidden lines.

Landscapes

  • Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Claims (9)

  1. Dispositif de maintien (2) d'une membrane (12) destiné à une application médicale oculaire, constitué d'une bague intérieure (5) réalisée dans un matériau rigide et d'une bague extérieure (6) réalisée dans un matériau élastique entre lesquelles est maintenue la membrane (12), la bague intérieure (5) étant entièrement prise et maintenue, de par la pression de la bague extérieure (6), dans un
    logement annulaire interne (13) de type gorge, le logement annulaire interne (13) s'étendant de l'intérieur vers l'extérieur dans la bague extérieure (6) et la bague extérieure (6) entourant la bague intérieure (5) sur sa face externe dans une zone de contact
    (14) parfaitement adaptée, la membrane
    (12) étant logée et maintenue dans la zone de contact (14) entre la bague intérieure (5)
    et la bague extérieure (6), la bague extérieure (6) étant réalisée dans un matériau souple et compatible avec une application médicale,
    caractérisé en ce que ladite bague extérieure
    recouvre entièrement et parfaitement la bague intérieure (5) sur sa face extérieure ainsi qu'en haut et en bas et en ce que la face interne de la bague intérieure (5) est si profondément enfoncée dans le logement annulaire (13) que la bague intérieure (5) n'entre jamais en contact avec l'œil.
  2. Dispositif de maintien (2) selon la revendication 1, caractérisé en ce que la bague extérieure (6) est réalisée en silicone et la bague intérieure (5) est réalisée en fil métallique.
  3. Dispositif de maintien (2) selon la revendication 1 ou 2, caractérisé en ce que la bague intérieure (5) se compose d'un fil métallique dont les extrémités sont soudées entre elles.
  4. Dispositif de maintien (2) selon les revendications 1 à 3, caractérisé en ce que la bague extérieure (6) présente, dans sa partie extérieure, une surface cunéiforme reposant sur l'œil,
    le logement annulaire (13) s'étendant de manière radiale et horizontale vers l'extérieur.
  5. Dispositif de serrage (1) d'une membrane (12) aux fins de son positionnement dans un dispositif de maintien (2) conformément aux revendications précédentes, caractérisé en ce qu'une partie supérieure (3) prévue pour le logement temporaire de la bague intérieure (5) et une partie inférieure (4) prévue pour le logement temporaire de la bague extérieure (6) du dispositif de maintien (2) sont
    mobiles l'une par rapport à l'autre, la partie inférieure et
    la partie supérieure étant configurées de manière à ce que la membrane (12) soit positionnable entre la partie supérieure (3) et la partie inférieure (4) et en ce que des moyens prévus dans le dispositif de serrage
    sont configurés de sorte que
    la bague intérieure (5), pendant le
    processus de serrage de la membrane (12), s'insère avec la membrane (12) dans le logement annulaire (13) correspondant de la bague externe,
    (6) le dispositif de serrage étant configuré de sorte que
    la membrane (12) entre la bague intérieure (5) et la
    bague extérieure (6) soit maintenue par pression et par friction dans la zone de contact (14)
    et que
    partie supérieure (3) est dotée d'un piston supérieur (7) pour recevoir la bague intérieure (5) et un cône de positionnement (9) se déplaçant de manière axiale par rapport au piston supérieur (7), le dispositif de serrage étant configuré de telle manière que le
    cône de positionnement (9)
    se compose de la bague intérieure (5) extractible du piston supérieur (7) et de la bague inférieure (5) dans le logement annulaire (13) de la bague extérieure (6) placée sur la partie inférieure (4) opposée, la bague extérieure (6) en matériau flexible et compatible avec un usage médical enveloppant parfaitement la bague intérieure (5) sur sa face extérieure mais aussi en haut et en bas et la face interne de la bague intérieure (5) étant si profondément insérée dans le logement annulaire (13) que
    la bague intérieure (5) n'entre jamais en contact avec l'œil.
  6. Dispositif de serrage (1) selon la revendication 5, caractérisé en ce que le cône de positionnement (9) peut être actionné axialement à l'aide d'une bague de pression (10) mobile par rapport à la partie supérieure (3).
  7. Dispositif de serrage (1) selon la revendication 5 ou 6, caractérisé en ce que le piston supérieur (7) comprend un piston de compression (11) (11) actionnable et mobile axialement par rapport à la partie supérieure (3) et en ce que le piston inférieur (8) correspondant de la partie inférieure (4) est mobile axialement, de sorte que la bague extérieure (6) posée sur le piston inférieur (8), grâce à l'actionnement du piston de compression (11) et au déplacement du piston supérieur (7) et du piston inférieur (8), est compressée par ce dernier sur un cône d'extraction (15) et se déforme autour de la bague intérieure (5) en serrant la membrane (12) entre la bague extérieure (6) et la bague intérieure (5).
  8. Dispositif de serrage (1) selon l'une des revendications 5 à 7, caractérisé en ce que le piston inférieur (8) a la forme convexe d'un globe oculaire et en ce que le piston inférieur (7) correspondant est concave.
  9. Dispositif de serrage (1) selon l'une des revendications 5 à 8, caractérisé en ce que la partie supérieure (3) et la partie inférieure (4) sont liées entre elles par une articulation rotative, les pistons (7, 8, 11) le cône de positionnement (9) et le cône d'extraction (15) étant positionnés en ligne au niveau du poste d'utilisation et de manière à basculer pour faciliter le chargement et le déchargement de la partie supérieure (3) au niveau de la partie inférieure (4).
EP13157162.2A 2012-03-02 2013-02-28 Dispositif de maintien pour une membrane pour une application médicale sur l''il et dispositif de tension correspondant Not-in-force EP2633838B1 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
DE202012100744U DE202012100744U1 (de) 2012-03-02 2012-03-02 Haltevorrichtung für eine Membran für eine medizinische Anwendung am Auge und Aufspannvorrichtung dazu

Publications (2)

Publication Number Publication Date
EP2633838A1 EP2633838A1 (fr) 2013-09-04
EP2633838B1 true EP2633838B1 (fr) 2020-04-29

Family

ID=46021863

Family Applications (1)

Application Number Title Priority Date Filing Date
EP13157162.2A Not-in-force EP2633838B1 (fr) 2012-03-02 2013-02-28 Dispositif de maintien pour une membrane pour une application médicale sur l''il et dispositif de tension correspondant

Country Status (2)

Country Link
EP (1) EP2633838B1 (fr)
DE (1) DE202012100744U1 (fr)

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI290055B (en) 2002-03-14 2007-11-21 Tissuetech Inc Amniotic membrane covering for a tissue surface and devices facilitating fastening of membranes
US20050143718A1 (en) * 2004-12-02 2005-06-30 Sie Ag Surgical Instrument Engineering Method for surgical treatment of a patient's eye by means of a laser
DE102006019017B4 (de) 2006-04-13 2016-09-22 Leibniz-Institut Für Polymerforschung Dresden E.V. Haltevorrichtung für eine Membran, Träger für die Haltevorrichtung und Verfahren zum Fixieren der Membran mittels der Haltevorrichtung an einem Auge

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
None *

Also Published As

Publication number Publication date
DE202012100744U1 (de) 2012-04-03
EP2633838A1 (fr) 2013-09-04

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